Senior Analytical Chemist - Research & Development
- Conduct analytical method development, method validation/verification, method transfer, stability studies, analytical testing in support of drug product development.
- Write method validation/verification protocols, reports, release specifications, test methods, test reports, CoAs, SOPs and prepare CMC required documentation in support of ANDA submission, per necessary.
- Work as Analytical Project Leaders on cross function teams such as Formulation group, Manufacturing Group, Quality Assurance, Quality Control, and interface with internal/external clients to meet required project timeline.
- Maintain laboratory equipment log, calibration log, inventory supplies, safety records, training records, notebooks, and all related documentation in compliance with the company SOPs, EHS standards, compendia and cGMP/GLP requirements. Attend/conduct in house training sessions as per to functions.
- Perform data review of cGMP/GLP analytical testing on raw materials, intermediates, finished products, stability testing, validation reports, qualification data per necessary.
- MS/BS in Analytical Chemistry, Pharmaceutics, or related field.
- MS with 5+ years or BS with 7+ years of experience in Analytical method development and validation in the pharmaceutical industry.
- Familiar with modern analytical instrumentation including HPLC, GC, KarlFisher, UV/VIS, FTIR, Dissolution testing.
- Knowledge of cGMP /GLP and compendia guidelines.
- Proficient in Microsoft Office toolkits and be able to write test methods, protocols, and reports.